An interventional study of Different tracheal tube cuff design in Intubation, Intratracheal, Pain, Postoperative and Dysphonia, sponsored by Taipei Veterans General Hospital, Taiwan. Completed at 1 site in Taiwan. Open to participants aged 20 Years to 90 Years. Per ClinicalTrials.gov, last updated 2021-09-17.
Sponsored by Taipei Veterans General Hospital, Taiwan · Not applicable, Interventional, and Prevention
This is a randomized controlled trial focusing on the effect of different tracheal tube cuff shape; the tapered-shaped tracheal tube cuff versus the cylindrical-shaped tracheal cuff in anterior cervical spine surgery.
High endotracheal cuff pressure (ETCP) during surgical retractor splay associates with recurrent laryngeal nerve paresis/ palsy and results in post-anterior cervical spine surgery (post-ACSS) dysphonia. Control of intraoperative ETCP during ACSS may benefit voice outcome. The taper-shaped tracheal tube cuff was originally designed as a new strategy to reduce fluid leakage across the conventional cylindrical cuff and prevention of ventilator associated pneumonia. Literature has revealed the just seal pressure for the tapered-shaped tracheal tube (TT) cuff was lower than conventional cylindrical cuff. Therefore the investigators hypothesize that use of a tapered-shaped ET cuff during the surgery can lead to a lower ETCP during retractors splay and improve voice recovery after ACSS. In this study, 80 patients were randomized into 2 groups, to receive endotracheal intubation using TaperGuard tracheal tube (tapered- shaped cuff) or a conventional tracheal tube (a cylindrical cuff). The just seal pressure, intraoperative cuff pressure, and postoperative sore throat and voice outcome are recorded and compared.
131 studies on the registry are indexed under Dysphonia; 34 are open to participants now.
This study's enrollment of 80 is above the median of 39 across 94 interventional studies indexed under Dysphonia.
Browse Dysphonia studies →Taipei Veterans General Hospital, Taiwan is the lead sponsor of 325 studies on the registry; 72 are open to participants now.
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Exclusion Criteria:
Tracheal intubation using TaperedGuard Tracheal Tube
Device: Different tracheal tube cuff design
Tracheal intubation using Hi-Contour Tracheal Tube
Device: Different tracheal tube cuff design
Comparison of effect between 2 different designs of tracheal tube cuff
Just seal tracheal tube cuff pressure
Minimal tracheal tube cuff pressure that prevent leakage of the ventilator system
Time frame: 1 minute after anesthesia and tracheal intubation
Tracheal tube cuff pressure on retractor splay
Cuff pressure when the retractors are set-up and removed
Time frame: Intraoperative monitoring
Sore throat-NRS
Postoperative sore throat, Numeric Rating Scale(NRS) 0\~10; 0=no sore throat; 10=maximal sore throat
Time frame: preOP(operation) day 1, post OP 2 hours, day 1, 2, 3, 7
Sore throat-VAS
Postoperative sore throat, Visual Analogue Scale (VAS) 0\~10; 0=no sore throat; 10=maximal sore throat
Time frame: preOP(operation) day 1, post OP 2 hours, day 1, 2, 3, 7
Subjective dysphonia
Hoarseness; Pitch; Loudness (0= none; 1= mild; 2= severe); compared with baseline
Time frame: preOP day 1, post OP 2 hours, day 1, 2, 3, 7
Subjective dysphonia-GRBAS score
GRBAS (Grade, Roughness, Breathiness, Asthenia, Strain) score (normal, slight, moderate, severe); compared with baseline
Time frame: One day before operation, and post operation day 1
Subjective dysphonia- Voice Handicap Index-10(VHI-10)
VHI-10 questionnaire (0 best\~40 worst; \>15 may be abnormal)
Time frame: One day before operation, and post operation day 7
Objective dysphonia
Software voice analysis; compared with baseline
Time frame: One day before operation(baseline), and post operation day 1
Postoperative complication
Any postoperative complication related complication
Time frame: After operation to post operation day 7
Plan to share: Yes — All of the individual participant data collected during the trial, after deidentification.
Supporting information: Study protocol, Sap, Icf, Csr
This study is completed, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.
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Taipei Veterans General Hospital, Taiwan